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"180. It is undisputed fact that biological drugs are synthesised by cells of living organisms, as opposed to chemical drugs which are produced by chemical synthesis. 'Biosimilars' are biological drugs that are similar to the innovator biological drug. Due to Owing to the complexity in the molecular arrangement and manufacturing process of a biological drug, it is not possible to replicate the structure and steps involved in the manufacture of the innovator biological drug and to produce an identical follow-on biological drug. Biosimilars, therefore, cannot be generic equivalents of the innovator biological drug. The generic drugs are characterised by their chemical and therapeutic equivalence to the original, low molecular weight chemical drugs. These are identical to the original product and are sold under the same chemical name.
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184. In order to avoid any confusion, it is mentioned (as admitted by the parties also) that the approval process for generic drugs is not the same as the approval process for biosimilars. Biological drugs are synthesised by cells of living organisms, as opposed to chemical drugs which are produced by chemical synthesis. The 'Biosimilars' are biological drugs that are similar to the innovator biological drug. It is admitted by all parties that it is not possible to replicate the structure and steps involved in the manufacture of the innovator biological drug and to produce an identical follow-on biological drug. Thus, biosimilars cannot be generic equivalents of the innovator biological drug."
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24. Biosimilars are designed to be highly similar to the reference product, but not identical. As discussed above, the Guidelines lay out the pathway for approval of biosimilar, however, these focus on the approval process and do not directly address patent issues. The determination of infringement must begin with understanding the scope of the patent(s) held by the reference biologic. We know that Patents can cover a wide range of protectable subject matter, including the biologic's molecular structure, the process by which it is manufactured, formulations, methods of use, and more. If the biosimilar or similar biologic utilizes or embodies any aspect that is patented by the reference biologic, only then there could be a case for patent infringement."

[emphasis supplied]

54. To appreciate the aforesaid submission made on behalf of the plaintiffs, a reference may be made to the Guidelines on Similar Biologics, 2016 issued by CDSCO and the Department of Biotechnology (hereinafter 'Biosimilar CS(COMM) 159/2024 Signing Date:23.07.2025 20:27:44 Guidelines'). The term 'reference biologic' has been defined in the glossary of the Biosimilar Guidelines in the following manner: